CN1416861A - Pharmaceutical composition with lactation function and preparation method thereof - Google Patents
Pharmaceutical composition with lactation function and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a pharmaceutical composition with a lactation function, which is characterized by being prepared from the following raw material medicines: 150 parts of cowherb seed, 100 parts of ricepaper pith, 150 parts of ricepaper pith, 190 parts of prepared rehmannia root, 50-75 parts of Chinese angelica, 80-125 parts of white paeony root, 36-56 parts of szechuan lovage rhizome, 100 parts of motherwort, 150 parts of mongolian snakegourd root and 150 parts of Mongolian snakegourd root.
Description
Technical field
The present invention relates to a kind of medicine and preparation method thereof, particularly relate to a kind of medicine and preparation method thereof with lactogenic function
Background technology
Breast milk is best Infants'feeding food owing to be subjected to the influence of various factors, surplus in the of nearly ten year over breastfeeding rate constantly descend, in being unfavorable for breastfeeding factor, puerperal hypogalactia (accounting for puerpera 20%-30%) is one of key factor.As everyone knows, the breast milk comprehensive nutrition contains the required various materials of infants growth and development, and is easy to sending and absorption; Also contain many immune factors in breast milk, the baby can improve its anti pathologic immunity power after absorbing.Therefore recover the normal lactogenic function of puerpera, improve breastfeeding rate, the anthropometic level that improves Chinese children is had important and far-reaching meaning.Motherland's medical science has far-reaching history to the research of hypogalactia of lying-in woman problem, generally speaking is dialectical deficiency and excess, and the branch another matter is controlled, the treatment of deficiency-syndrome by reinforcement, Sheng person dredges it, promptly treats the hypogalactia of all void of QI and blood with the method that fills blood, with the hypogalactia of the soothing the liver strongly fragrant method relieving stagnation of QI and the depress liver that looses, and assistant is with the agent of lactogenesis.
Summary of the invention
The object of the invention is to provide a kind of pharmaceutical composition with lactogenic function and preparation method thereof.
The present invention seeks to be achieved through the following technical solutions:
Semen Vaccariae 100-150 weight portion Medulla Tetrapanacis 100-150 weight portion
Radix Rehmanniae Preparata 125-190 weight portion Radix Angelicae Sinensis 50-75 weight portion
Radix Paeoniae Alba 80-125 weight portion Rhizoma Chuanxiong 36-56 weight portion
Herba Leonuri 100-150 weight portion Radix Trichosanthis 100-150 weight portion
More than eight flavors, Radix Rehmanniae Preparata, Radix Angelicae Sinensis, Rhizoma Chuanxiong is made solvent with 70-80% ethanol, carries out percolation, percolate reclaims ethanol, and is concentrated standby; Medulla Tetrapanacis was soaked 1-3 hour, decocted 1-3 hour, filtered, decoct 1-3 time in filtrate adding Semen Vaccariae, the Radix Paeoniae Alba, the Herba Leonuri, each 1-2 hour, filter filtrate for later use, Radix Trichosanthis is used hot water warm macerating 1-3 hour, filter, filtrate and above-mentioned each extracting solution merge, and concentrate, standing over night is got supernatant concentration to clear paste.Add acceptable auxiliary or excipient on the preparation, make clinical acceptable forms, as tablet, capsule, oral liquid, granule, soft extract etc.
The method of quality control of the soft extract of preparation of pharmaceutical compositions of the present invention comprises to be differentiated and/or content assaying method.Wherein discrimination method can be selected from one or more in the following discrimination method:
1; get soft extract 50ml of the present invention, add dehydrated alcohol 70ml, the limit edged stirs; restir 8-12 minute; leave standstill, and inclines and gets upper strata liquid evaporate to dryness, and residue adds saturated nacl aqueous solution 20ml to be made dissolving and be transferred in the separatory funnel; with water saturation n-butanol extraction 2-4 time; each 10-30ml, merge n-butyl alcohol liquid, with 3-5% ammonia spirit washing 1-3 time; each 10-30ml; reuse saturated nacl aqueous solution washing 2-4 time, 10-30ml gets n-butyl alcohol liquid evaporate to dryness; residue adds methanol 15ml; supersound process 10-20 minute at every turn, filtration, filtrate evaporate to dryness; residue adds methanol 1ml makes dissolving, as need testing solution; Other gets Semen Vaccariae control medicinal material 5 weight portions, adds 60-90 ℃ of petroleum ether 10-30ml, and reflux 1-1.5 hour, filter, filtering residue volatilizes, and adds ethanol 20-30ml, reflux 20-35 minute, puts cold; Filter, filtrate evaporate to dryness, residue add saturated nacl aqueous solution 20-30ml to be made dissolving and is transferred in the separatory funnel, shines medical material solution in pairs with legal system; Test according to thin layer chromatography, drawing above-mentioned two kinds of each 5ul of solution puts respectively on same silica gel weight portion lamellae, with 14-16: 38-41: 20-24: lower floor's solution that 8-11 chloroform-ethyl acetate--methanol--water was placed 10-12 hour below 5～10 ℃ is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to speckle colour developing at 100-110 ℃; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color;
2, get soft extract 50ml of the present invention, add dehydrated alcohol 70ml limit edged and stir restir 8-12 minute, leave standstill, incline and get upper strata liquid, 25-35ml adds diethyl ether, standing over night is inclined and is got upper strata liquid, steams near and does, add dehydrated alcohol 7ml, ether 3ml supersound process 10-20 minute, gets upper strata liquid, the evaporate to dryness residue adds ethanol 1ml dissolving, as need testing solution; Other gets Radix Rehmanniae Preparata control medicinal material 5 weight portions, and section adds ethanol 18-22ml, and reflux 0.5-1 hour, put coldly, filter the filtrate evaporate to dryness, residue adds methanol 1ml makes dissolving, in contrast medical material solution; According to thin layer chromatography test, draw above-mentioned two kinds of each 5ul of solution, put respectively on same silica gel weight portion lamellae, be developing solvent with 60-90 ℃ of petroleum ether-ethanol acetate of 1-2: 1-2, launch, take out, dry; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical yellow spotting;
3, get soft extract 8g of the present invention, accurate claim surely, add water 18-22ml and fully stir and make dissolving, pass through macroporous adsorptive resins, wet method dress post, internal diameter 12-16mm, water 150-250ml eluting discards water liquid, reuse ethanol 60-80ml eluting is collected ethanol liquid, and evaporate to dryness, residue add methanol 13-16ml, supersound process 11-20 minute, filter, filtrate is transferred in the 25ml measuring bottle, add methanol to scale, shake up, get above-mentioned solution 15ml, evaporate to dryness, residue add methanol 1-2ml makes dissolving, as need testing solution; Other gets the peoniflorin reference substance, adds methanol and makes the solution that every 1ml contains 2mg, in contrast product solution; Test according to thin layer chromatography, draw above-mentioned two kinds of each 4ul of solution, put respectively on same silica gel weight portion lamellae, with 38-42: 3-6: 8-12: 0.1-0.3 chloroform-ethyl acetate-methanol-formic acid is developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear that hot blast blows to the speckle colour developing; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
4, get soft extract 50ml of the present invention, add dehydrated alcohol 70ml limit edged and stir restir 8-12 minute, leave standstill, incline and get upper strata liquid, 25-35ml adds diethyl ether, standing over night is inclined and is got upper strata liquid, steams near and does, add dehydrated alcohol 7ml, ether 3ml supersound process 8-12 minute, gets upper strata liquid, the evaporate to dryness residue adds ethanol 1ml dissolving, as need testing solution; Other gets the citrulline reference substance, adds Diluted Alcohol and makes the solution that every 1ml contains the 1m weight portion, in contrast product solution; Test according to thin layer chromatography, draw need testing solution 15 μ l, reference substance solution 1 μ l, put respectively on same silica gel weight portion lamellae, with 6-10: 1-2: 1-2: 2-4 n-butyl alcohol-dehydrated alcohol-glacial acetic acid-water is developing solvent, launches, take out, dry, spray is with ninhydrin solution, and it is clear to be heated to speckle colour developing at 100-110 ℃; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
Content assaying method is in the method for quality control of the soft extract of the inventive method preparation:
According to high effective liquid chromatography for measuring, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; 24-26: 70-80 methanol--water is mobile phase; The detection wavelength is 230nm; Number of theoretical plate calculates by peoniflorin should be not less than 3000; The preparation of reference substance solution, precision take by weighing peoniflorin reference substance 10mg, put in the 50ml measuring bottle, add dissolve with methanol and are diluted to scale, shake up; The accurate 5ml that draws puts and adds methanol in the 10ml measuring bottle and be diluted to scale, shakes up, that is, every 1ml contains peoniflorin 0.1mg.Soft extract 8g of the present invention is got in the preparation of need testing solution, accurate claims surely, adds water 20ml and fully stirs and make dissolving, by macroporous adsorptive resins, wet method dress post, internal diameter 12-16mm, water 150-250ml eluting discards water liquid, reuse ethanol 60-80ml eluting, collect ethanol liquid, evaporate to dryness, residue add methanol 12-16ml, supersound process 12-16 minute, filter, filtrate is transferred in the 25ml measuring bottle, add methanol to scale, shake up, promptly; Algoscopy, accurate respectively reference substance solution and each 10ul of need testing solution of drawing injects chromatograph of liquid, measures, promptly; The every 1g of soft extract of the present invention contains peoniflorin (C
23H
28O
11) must not be less than 0.25mg.
The soft extract of preparation of pharmaceutical compositions of the present invention (increasing emulsifiable paste) increases emulsifiable paste 14-28g/kg and irritated stomach 3 the insufficient SD pure lines of experimental lactogenic rat, can make the filial mice amount of sucking showed increased, the filial mice body.After heavily growth acceleration, mouse stomach 10,20 and 40g/kg increase emulsifiable paste, no matter be the female Mus of experimental lactogenic deficiency or normal lactation, serum prolactin antagonist secretion level all increases, and high cylindrical cell increases in the mammary gland, and the filial mice speed of growth is accelerated, and endurance improves.Electron microscope observation is the result show, experimental scarce wet nurse Mus, heavy dose of group increases emulsifiable paste increases adenohypophysis lactotrophic cell volume, and rough endoplasmic reticulum quantity and bud phenomenon increase.The transportation corpusculum is abundanter.
Following experiment material all is applicable to the zoopery example of this description.
1, be subjected to the reagent thing: increase emulsifiable paste (promptly increasing emulsifiable paste), 4g crude drug/ml is by Zhangzhou Inst. of Pharmaceuticals development and lot number 940202 is provided.Paspertin metoclopramide (metoclopramide), 20mg/1ml, people pharmaceutical factory of Tianjin aminoacid company produces, lot number 930507.
2, animal: SD is sheerly rat, 250-280g, and available from field, Shanghai Sippr-BK laboratory animal supply company limited, No. the 65th, the real moving accurate word of individual event of cleaning level quality certification Shanghai doctor; Kunming mouse, 26-30g is available from Sanitation and Anti-epidemic Station, Fujian Prov. laboratory animal field.Accurate No. 92001 of the moving individual event of regular grade quality certification Fujian doctor.Animal Lab.: the moving bar 94007 of regular grade quality certification Fujian doctor.
Experimental example 1:Experimental lactogenic is secreted the influence of not enough rat filial mice amount of sucking and body weight: getting childbirth on the same day and filial mice number has SD pure lines rat 30 nests that are less than 8/nest, pick and abandon unnecessary filial mice, the filial mice number average that makes every nest nurture is 8 and supplies experiment, and is divided into 5 groups at random, every group 6 nest (48 of filial mices).Female Mus and filial mice were lived apart 6 hours, take by weighing each filial mice as basic body weight with TG927C type single-deck photoelectric analytical balance.Then female Mus is put and returned the primitive pit lactication 1 hour, the same method claims the filial mice body weight.Ask before the administration average and standard deviation in the group with the difference of secondary body weight as the suction breast figureofmerit of each filial mice.Organize female Mus lumbar injection (ip) diethylstilbestrol 8mg/kg to each then, the next day once (q.o.d) totally 2 times, and irritate stomach (ig) respectively and increase emulsifiable paste 7,14,28g/kg, positive controls ig paspertin metoclopramide 10mg/kg, negative control group ig water 11.21/kg, qd, continuous 3 days, after the last administration 24 hours, survey the body weight and the amount of sucking of each filial mice again, with the comparison of administration, carry out the t check respectively, see table 1 and table 2 for details.
Table 1 increases the influence of emulsifiable paste to the filial mice amount of sucking of the not enough rat of lactogenic
Female the Mus administration situation filial mice amount of sucking (mg/h, xSD) the female young number filial mice number of group
Before (ig, qd * 3) administration after the administration 1, water 11.2ml/kg 6 48 0.327 ± 0.144 0.293 ± 0.0982, paspertin metoclopramide 10mg/kg 6 48 0.335 ± 0.095 0.363 ± 0.10**3, increase emulsifiable paste 28g/kg 6 48 0.302 ± 0.064 0.409 ± 0.092***4, increase emulsifiable paste 7g/kg 6 48 0.330 ± 0.083 0.375 ± 0.119**5, increase emulsifiable paste 6 48 0.321 ± 0.075 0.331 ± 0.088
* P＜0.05, * * P＜001, * * * P＜0.001 and group 1 be (down with) relatively
As seen from Table 1, respectively organize per hour (h) amount of sucking average close (P＞0.05) of filial mice before the administration, after the injection diethylstilbestrol causes the not enough model of lactogenic and awards different drug treating, each organizes filial mice, and per hour the amount of sucking average is then different, the amount of sucking from organize 1 to the group 5 respectively variate be-10.4%, 8.8%, 35.43%, 13.64% and 3.12%, the result shows, not enough SD is that female Mus ig increases emulsifiable paste 14 and 28g/kg can significantly increase its lactation amount to lactogenic, and the curative effect of heavy dose of group surpasses positive control drug paspertin metoclopramide group (P2.3＜0.05).
Table 2 increases the influence of emulsifiable paste to the filial mice speed of growth of the not enough rat of experimental lactogenic
Female Mus administration situation filial mice amount of sucking (mg/h, the group filial mice number of x ± SD)
Before (ig, qd * 3) administration after the administration 1, water 11.2ml/kg 48 8.026 ± 0.938 3.48 ± 0.7532, paspertin metoclopramide 10mg/kg 48 7.994 ± 1.24 3.861 ± 0.381**3, increase emulsifiable paste 28g/kg 48 8.218 ± 0.722 3.886 ± 0.713*4, increase emulsifiable paste 14g/kg 48 8.103 ± 0.883 3.61 ± 0.6115, increase emulsifiable paste 7g/kg 48 8.117 ± 0.927 3.416 ± 0.703
Table 2 prompting, the young Mus that increases the not enough SD rat nurture of lactogenic that emulsifiable paste brings out diethylstilbestrol has the growth of promotion effect, the rate of body weight gain (11.64%) and negative control group comparing difference significance (P＜0.05) of heavy dose of group filial mice.
Experimental example 2:Influence to normal lactation mice and filial mice thereof: Kunming mouse 50 nests, keeping the filial mice number average the 5th day puerperal is 9/nest, gets 40 nests at random and is divided into 5 groups, every group 8 nest, 72 of filial mices.Separate to take by weighing each filial mice body weight with the torsion sky in 6 hours with female filial mice, give female Mus ig paspertin metoclopramide 7mg/kg respectively, increase emulsifiable paste 10,20,40g/kg, perhaps water 20ml/kg, qd * 7 day.Claim the filial mice body weight again with method next day and measure each filial mice swimming durability (table 3).Adopt measured by radioimmunoassay (the prolactin antagonist medicine box is available from northern immunoreagent institute) female Mus serum prolactin antagonist (PRL) level (table 4) and get breast biopsy
Table 3 increases the influence of emulsifiable paste to the filial mice speed of growth and swimming endurance
Breast milk administration situation filial mice body weight (g, the filial mice swimming time group filial mice number of x ± SD)
(ig, pd * 7) basic body weight 7 daily gain values (second, x ± SD) 1, water 20ml/kg 72 3.314 ± 0.437 2.60 ± 0.25 65.6 ± 19.72, paspertin metoclopramide 7mg/kg 72 3.151 ± 0.41 2.768 ± 0.39** 67.3 ± 19.93, increase emulsifiable paste 40g/kg 72 3.153 ± 0.559 2.954 ± 0.267***, 113.1 ± 53.1***4, increase emulsifiable paste 20g/kg 72 3.117 ± 0.387 2.762 ± 0.573 82.8 ± 27.7***5, increase emulsifiable paste 10/kg 72 3.131 ± 0.521 2.631 ± 0.61 64.3 ± 23.5
As can be seen from Table 3, to the filial mice that the female Mus of the Kunming kind of normal lactation is fed, give female Mus by increase the effect that emulsifiable paste has certain promotion filial mice growth, strengthens swimming endurance, heavy dose of group is with negative
Matched group compares, and the p value of above-mentioned two indexs is all less than 0.001.
Table 4 increases the influence of emulsifiable paste to the female Mus blood-serum P of normal lactation R1 level
The horizontal PRL group of administration situation levels of serum PRL Mus number
(ig, qd * 7) (mg/ml, rate of rise (%) the P value 1 of x ± SD), water 20ml/kg 8 6.35 ± 2.242, paspertin metoclopramide 7mg/kg 8 7.82 ± 2.41 23.15＞0.053, increase emulsifiable paste 40g/kg 8 11.36 ± 2.58 78.90＜0.014, increase emulsifiable paste 20g/kg 8 9.25 ± 3.30 45.67＜0.055, increase emulsifiable paste 10g/kg 8 7.31 ± 3.41 15.12＞0.05
Table 4 prompting, big or middle amount increase emulsifiable paste can promote female Mus secretion age of sucking prolactin antagonist, and its effect surpasses positive control drug paspertin metoclopramide (P
2,3＜0.05).
Mammary gland sheet (H.E dyeing) light microscopy checking result, the mammary gland tissue of all tested mices all is variation age of sucking, and the fibrous tissue layer is poor between lobule; Even can not see fibrous tissue and separate.To secrete the high columnar epithelial cell of vigorous mammary gland is index, and negative control group is no more than 40%, accounts for clear majority and increase the heavy dose of high columnar epithelial cell of organizing mammary gland of emulsifiable paste, points out its galactopoiesis activity more active.
Experimental example 3:The shadow p of not enough mice of experimental lactogenic and filial mice thereof to Kunming mouse 40 nests, is kept the several 8/nests of filial mice in the 4th day minute puerperium, be divided into 5 groups at random, every group 8 nest.Female Mus is ip diethylstilbestrol 11mg/kg respectively, and gd * 3 day increase emulsifiable paste or contrast medicine, continuous 5 days by ig shown in the table 5 simultaneously.Next day after the last administration, the same method is surveyed the increment of filial mice body weight, swimming endurance.Female Mus levels of serum PRL level, breast biopsy is observed adenohypophysis lactotrophic cell ultrastructure simultaneously.The results are shown in Table 5,6.
Table 5 increases emulsifiable paste to the filial mice body weight of the not enough mice of experimental lactogenic and the influence of endurance
Female Mus administration situation filial mice body weight (g, the filial mice endurance of x ± SD) (second, group filial mice number
(ig, qd * 5) basic value 5 daily gain value x ± SD) 1, water 20ml/kg 64 2.792 ± 0.572 1.412 ± 0.452 74.8 ± 17.02, paspertin metoclopramide 7mg/kg 64 2.822 ± 0.442 1.669 ± 0.403**, 84.0 ± 17.5**3, increase emulsifiable paste 40g/kg 64 2.794 ± 0.334 1.819 ± 0.442***, 96.1 ± 7.0***4, increase emulsifiable paste 20g/kg 64 2.851 ± 0.542 1.650 ± 0.222**, 86.3 ± 21.5**5, increase emulsifiable paste 10g/kg 64 2.796 ± 0.611 1.420 ± 0.344 79.8 ± 18.1
Table 5 prompting increases that emulsifiable paste is oral to make experimental lactogenic, and the filial mice growth of not enough female Mus nurture has more obviously to be quickened, and strengthens its swimming endurance.
Table 6 increases the influence of emulsifiable paste to the not enough mice serum PR1 of experimental lactogenic level
The horizontal PRL group of administration situation levels of serum PRL Mus number
(ig, qd * 7) (mg/ml, rate of rise (%) the P value 1 of x ± SD), water 20ml/kg 8 7.52 ± 1.002, paspertin metoclopramide 7mg/kg 8 9.60 ± 1.07 27.66＜0.0013, increase emulsifiable paste 40g/kg 8 9.41 ± 1.90 25.13＜0.054, increase emulsifiable paste 20g/kg 8 8.55 ± 2.28 13.70＞0.055, increase emulsifiable paste 10g/kg 8 7.76 ± 1.96 3.19＞0.05
As seen from Table 6, increase breast, the lactogenic that child care cream brings out diethylstilbestrol, not enough female Mus has the PRL of promotion release action, and heavy dose of group compares difference significance (P＜0.05) with negative control group.
The mammary gland section is (H.E dyeing) light microscopy checking result show, heavy dose of group increases emulsifiable paste and obviously increases high cylindrical cell proportion.Adenohypophysis PR1 cell (sodium acetate, the dyeing of structure rafter lead plumbate) ultrathin section electron microscope observation is found, compare with negative control group (G), it is bigger that heavy dose increases emulsifiable paste group adenohypophysis PR1 cell volume, rough endoplasmic reticulum quantity and blastogenesis phenomenon are more, transport vesicle is abundanter, and the function of prompting PRL cell is more vigorous.
Experimental example 4:Increase the clinical trial of emulsifiable paste to primipara and hypogalactia primipara galgctogogue action
Diagnostic criteria: hypogalactia diagnostic criteria: puerpera's galactopoiesis be reduced to completely without, do not have milk and expand, check that breast is full, do not have during extruding the milk secretion or two a little; The hypogalactia degree: (1) is slight: need mend the milk replacer (or storehouse breast) of awarding 1/3～＜1/2 amount every day; (2) moderate: need mend the milk replacer (or storehouse breast) of awarding 1/2～2/3 amount every day; (3) severe: need mend the milk replacer of awarding more than 2/3 (or storehouse breast) every day.
Observation index: the galgctogogue action observation index, measure the galactopoiesis amount indirectly: measured one by one up at 8 o'clock in afternoon and feed breast front and back infant weights (measuring with accurate platform scale), 12 hours lactation amounts of indirect calculation puerpera every day from the morning 8.And press 1g=1ml and convert; Day by day calculate the lactication amount of mending; Detect in 2 hours puerperal and serum prolactin when leaving hospital, draw blood the morning on an empty stomach.
Therapeutic Method: test group (comprising the expansion group) increases the each 25ml of emulsifiable paste, every day 3 times; Boiled water is taken after mixing it with water after meal.The course of treatment: began to take medicine the same day in puerperal, and serve on 3-5 days, and began to observe above-mentioned every index, Continuous Observation 3 days (prolactin antagonist detects in required time) second day puerperal.Begin when hypogalactia primipara goes to a doctor to take medicine, serve on 6 days.Matched group: the each 25ml of SIWU TANG (cream), every day 3 times, boiled water is taken after mixing it with water after meal.The course of treatment: same test group; Test group and matched group were by random assortment in 1: 1, and the region between the heart and the diaphragm method is offerd medicine.Duration of test is stopped using, and all have the Chinese and western drugs of galgctogogue action.
The result
1, two groups of ordinary circumstance contrasts of test group and matched group (seeing Table 7)
Two groups of ordinary circumstance contrasts of table 7 test group and matched group
Example age birth process baby situation hypogalactia course of treatment degree
Number (year) mature non-mature non-well bad (day) light middle weight
Natural labor natural labor
Test group 26.63 ± 2.79 50 0 50 0 4.70 ± 0.51 the primipara
50
Matched group 26.84 ± 2.50 50 0 50 0 4.98 ± 0.62
Test group 27.80 ± 3.02 96 15 0 5.2 ± 0.9 861 hypogalactias, 15 primipara's matched groups 27.06 ± 2.73 78 15 0 5.8 ± 1.2 933
Table 7 a liang group data is learned processing by statistics, and all＞0.1 two groups of promptings are in age, birth process, infantile health situation for the P value, and aspects such as the course of treatment and hypogalactia degree are basic identical or similar, and comparability is preferably arranged.
2, the observation of primipara's galgctogogue action
(1) lactation amount and the baby is mended the influence of lactication amount before and after the primipara treats: (seeing Table 8)
Lactation amount and the baby is mended the influence (X ± SD) of lactication amount before and after table 8 primipara treats
The routine number of example number lactation amount (m1/12h) is mended lactication amount (ml/2h)
Control preceding 122.01 ± 52.04 21.00 ± 33.21 test group 50 50
Control back 228.94 ± 122.74** Δ Δ 12.90 ± 32.76
Control preceding 89.60 ± 37.67 23.50 ± 29.26 matched groups 50 50
Control back 132.56 ± 57.67**, 17.80 ± 27.07*
Control preceding 94.41 ± 69.35 and enlarge 46
Control back 197.82 ± 62.21**
Contrast * P＜0.01 test group before and after the treatment and contrast knob than Δ P＞0.05
**P＜0.001?ΔΔP＜0.001
Shown in the table 8, feed situation about increasing weight before and after the breast by measuring 12 hours (h) babies, measure puerpera's lactation amount (1g=1ml conversion) indirectly, the result shows, test group, matched group and expansion group all can obviously increase puerpera's lactation amount, rise to 288.94ml/12h by 122.01ml/12h respectively, 89.6ml/12h rises to 132.56ml/12h and 94.4ml/12h rises to 197.82ml/12h.Contrast before and after the treatment, the difference highly significant, the P value is all＜0.001.And the lactation amount of test group obviously is better than matched group, P＜0.001.When increasing cesarean lactation, can also reduce baby's benefit lactication amount, contrast before and after test group and the treatment of control group, difference highly significant, P＜0.01.But the test group end is seen and is better than matched group, P＞0.05.
3, the primipara treats the influence of front and back to prolactin secretion: (seeing Table 9)
Table 9, primipara treat the influence of front and back to prolactin secretion
Example number lactotropin (ug/l)
Control preceding 164.32 ± 119.29 test group 50
Control back 207.46 ± 129.58**
Control preceding 169.32 ± 132.61 matched groups 50
Control back 169.01 ± 97.28
Contrast * * P＜0.05*P＞0.05 before and after the treatment
Shown in the table 9, can obviously promote the primipara to secrete after the test group treatment, with ratio before the treatment, significant difference, P＜0.05, and matched group see that this effect is arranged.
4, the observation of hypogalactia primipara galgctogogue action
Before and after hypogalactia primipara treats the baby is mended the influence of lactication amount: (seeing Table 10)
Before and after table 10 hypogalactia primipara treats the baby is mended the influence (X ± SD) of lactication amount
The example number is mended lactication amount (ml/ day)
Control preceding 74.66 ± 25.03 test group 15
Control back 2.00 ± 7.74* Δ
Control preceding 78.00 ± 46.08 matched groups 15
Control back 22.00 ± 26.77*
Control preceding 159.16 ± 103.76 expansion groups 15
Control back 46.68 ± 80.63* Δ
* P before and after the treatment＜0.001 test group, expansion group and matched group are than Δ P＜0.01.
Shown in the table 10, three groups of benefit lactication amounts that all can obviously reduce the hypogalactia primipara to the baby are organized in test group, matched group, expansion, and by dropping to 2ml/ day E 74.66ml/ day, 78ml/ day drops to 22ml/ day respectively, and 159.16ml/ day drops to 46.68ml/ day.Wherein test group, expansion group all are better than matched group.
5, the hypogalactia primipara treats the influence of front and back to prolactin secretion: (seeing Table 11)
Before and after table 11 hypogalactia primipara treats to the influence of prolactin secretion (x ± SD)
Example number lactotropin (ug/L)
Control preceding 60.66 ± 15.95
15
Control back 100.80 ± 27.95*
P＜0.001
Shown in the table 11, increase the secretion that can obviously promote hypogalactia primipara lactotropin after emulsifiable paste is treated,
With contrast before the treatment, difference highly significant, P＜0.001.
6, the observation of untoward reaction
Detect blood, urine band rule 146 examples altogether before and after increasing the emulsifiable paste treatment.ALT, BUN, each 65 example of electrocardiogram.Wherein control preceding Hb＜100g/L29 example (physiologic anemia), control back 4 examples and recover normal, other is not seen and increases the weight of; Before WBC controls＞10 * 10
9/ L＞10 examples, all recover after controlling normal outside, abnormal change is seen at the equal end of other test item, to taking the clinical observation that increases emulsifiable paste 146 examples, there is no untoward reaction, has indivedual puerperas to reflect that this product mouthfeel is poor slightly, the clinical consumption of prompting this product is safe.
Show by clinical test results 146 routine primiparas and 66 routine hypogalactia primiparas, increase emulsifiable paste and can obviously increase puerpera's lactation amount, reduce baby's benefit lactication amount, promote the plain secretion of cesarean lactation, untoward reaction is not seen in clinical observation, it is a kind of pure natural galactopoietic of effective and safe, be the call of response World Health Organization (WHO), advocate, promote breast feeding condition is provided.
Embodiment 1:
Semen Vaccariae 133g Medulla Tetrapanacis 133g
Radix Rehmanniae Preparata 167g Radix Angelicae Sinensis 67g
Radix Paeoniae Alba 111g Rhizoma Chuanxiong 50g
Herba Leonuri 133g Radix Trichosanthis 133g
More than eight flavors, Radix Rehmanniae Preparata, Radix Angelicae Sinensis, Rhizoma Chuanxiong is made solvent with 70% ethanol, carries out percolation, percolate reclaims ethanol, and is concentrated standby; Medulla Tetrapanacis was soaked 2 hours, decocted 1 hour, filtered, decoct 2 times in filtrate adding Semen Vaccariae, the Radix Paeoniae Alba, the Herba Leonuri, each 1.5 hours, filter, filtrate for later use, Radix Trichosanthis is used hot water warm macerating 2 hours, filters, and filtrate and above-mentioned each extracting solution merge, concentrate, standing over night is got supernatant concentration to clear paste, makes soft extract 1000g.
Embodiment 2:
Semen Vaccariae 133g Medulla Tetrapanacis 133g Radix Rehmanniae Preparata 167g
Radix Angelicae Sinensis 67g Radix Paeoniae Alba 111g Rhizoma Chuanxiong 50g
Herba Leonuri 133g Radix Trichosanthis 133g
More than eight flavors, Radix Rehmanniae Preparata 80% ethanol, Radix Angelicae Sinensis, Rhizoma Chuanxiong is made solvent with 70% ethanol, carries out percolation, percolate recovery ethanol is concentrated standby; Medulla Tetrapanacis was soaked 1 hour, decocted 2 hours, filtered, decoct 1 time in filtrate adding Semen Vaccariae, the Radix Paeoniae Alba, the Herba Leonuri, 1.5 hours, filter, filtrate for later use, Radix Trichosanthis is used hot water warm macerating 2 hours, filters, and filtrate and above-mentioned each extracting solution merge, concentrate, standing over night is got supernatant concentration to clear paste, adds dextrin and makes the 300g granule.
Embodiment 3:The method of quality control of the soft extract of preparation of pharmaceutical compositions of the present invention
Get soft extract 50ml of the present invention, add dehydrated alcohol 70ml, the limit edged stirs, restir 10 minutes, leave standstill, incline and get upper strata liquid evaporate to dryness, residue add saturated nacl aqueous solution 20ml make the dissolving and be transferred in the separatory funnel, with water saturation n-butanol extraction 3 times, each 20ml merges n-butyl alcohol liquid, with 5% ammonia spirit washing 2 times, each 20ml, reuse saturated nacl aqueous solution washing 3 times, each 20ml gets n-butyl alcohol liquid evaporate to dryness, residue adds methanol 15ml, ultrasonic place 15 minutes filters the filtrate evaporate to dryness, residue adds methanol 1ml makes dissolving, as need testing solution; Other gets Semen Vaccariae control medicinal material 5 weight portions, adds 60-90 ℃ of petroleum ether 20ml, and reflux 1 hour filters, and filtering residue volatilizes, and adds ethanol 25ml, and reflux 30 minutes is put cold; Filter, filtrate evaporate to dryness, residue add saturated nacl aqueous solution 20ml to be made dissolving and is transferred in the separatory funnel, shines medical material solution in pairs with legal system; Test according to thin layer chromatography, drawing above-mentioned two kinds of each 5ul of solution puts respectively on same silica gel weight portion lamellae, with 15: 40: 22: lower floor's solution that 10 chloroforms-ethyl acetate--methanol---water was placed 12 hours below 5～10 ℃ was developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to speckle colour developing at 105 ℃; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color;
Get soft extract 50ml of the present invention, add dehydrated alcohol 70ml limit edged and stir restir 10 minutes, leave standstill, incline and get upper strata liquid, 30ml adds diethyl ether, standing over night is inclined and is got upper strata liquid, steams near and does, add dehydrated alcohol 7ml, ether 3ml, supersound process 10 minutes is got upper strata liquid, the evaporate to dryness residue adds ethanol 1ml dissolving, as need testing solution; Other gets Radix Rehmanniae Preparata control medicinal material 5 weight portions, and section adds ethanol 20ml, and reflux 0.5 hour is put coldly, filters the filtrate evaporate to dryness, and residue adds methanol 1ml makes dissolving, in contrast medical material solution; According to the thin layer chromatography test, draw above-mentioned two kinds of each 5ul of solution, put respectively on same silica gel weight portion lamellae, be developing solvent with 2: 1 60-90 ℃ petroleum ether-ethanol acetate, launch, take out, dry; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical yellow spotting;
Get soft extract 8g of the present invention, accurate claim surely, add water 20ml and fully stir and make dissolving, by the D101 macroporous adsorptive resins, wet method dress post, internal diameter 15mm, water 200ml eluting discards water liquid, reuse ethanol 70ml eluting is collected ethanol liquid, and evaporate to dryness, residue add methanol 15ml, supersound process 15 minutes filters, and filtrate is transferred in the 25ml measuring bottle, add methanol to scale, shake up, get above-mentioned solution 15ml, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Other gets the peoniflorin reference substance, adds methanol and makes the solution that every 1ml contains 2mg, in contrast product solution; According to the thin layer chromatography test, draw above-mentioned two kinds of each 4ul of solution, put respectively on same silica gel weight portion lamellae, with 40: 5: 10: 0.2 chloroform-ethyl acetate-methanol-formic acid was developing solvent, launched, and took out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear that hot blast blows to the speckle colour developing; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
Get soft extract 50ml of the present invention, add dehydrated alcohol 70ml limit edged and stir restir 10 minutes, leave standstill, incline and get upper strata liquid, 30ml adds diethyl ether, standing over night is inclined and is got upper strata liquid, steams near and does, add dehydrated alcohol 7ml, ether 3ml, supersound process 10 minutes is got upper strata liquid, the evaporate to dryness residue adds ethanol 1ml dissolving, as need testing solution; Other gets the citrulline reference substance, adds Diluted Alcohol and makes the solution that every 1ml contains the 1m weight portion, in contrast product solution; Test according to thin layer chromatography, draw need testing solution 15 μ l, reference substance solution 1 μ l, put respectively on same silica gel weight portion lamellae, with 8: 2: 2: 3 n-butyl alcohol-dehydrated alcohol-glacial acetic acid-water is developing solvent, launches, take out, dry, spray is with ninhydrin solution, and it is clear to be heated to speckle colour developing at 105 ℃; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;
Assay: according to high effective liquid chromatography for measuring, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; 25: 75 methanol--water is mobile phase; The detection wavelength is 230nm; Number of theoretical plate calculates by peoniflorin should be not less than 3000; The preparation of reference substance solution, precision take by weighing peoniflorin reference substance 10mg, put in the 50ml measuring bottle, add dissolve with methanol and are diluted to scale, shake up; The accurate 5ml that draws puts and adds methanol in the 10ml measuring bottle and be diluted to scale, shakes up, that is, every 1ml contains peoniflorin 0.1mg.Soft extract 8g of the present invention is got in the preparation of need testing solution, accurate claims surely, adds water 20ml and fully stirs and make dissolving, by the D101 macroporous adsorptive resins, wet method dress post, internal diameter 15mm, water 200ml eluting discards water liquid, reuse ethanol 70ml eluting, collect ethanol liquid, evaporate to dryness, residue add methanol 15ml, supersound process 15 minutes filters, and filtrate is transferred in the 25ml measuring bottle, add methanol to scale, shake up, promptly; Algoscopy, accurate respectively reference substance solution and each 10ul of need testing solution of drawing injects chromatograph of liquid, measures, promptly; The every 1g of soft extract of the present invention contains peoniflorin (C
23H
28O
11) must not be less than 0.25mg.
Claims (10)
1, a kind of pharmaceutical composition with lactogenic function is characterized in that this pharmaceutical composition made by following crude drug:
Semen Vaccariae 100-150 weight portion Medulla Tetrapanacis 100-150 weight portion
Radix Rehmanniae Preparata 125-190 weight portion Radix Angelicae Sinensis 50-75 weight portion
Radix Paeoniae Alba 80-125 weight portion Rhizoma Chuanxiong 36-56 weight portion
Herba Leonuri 100-150 weight portion Radix Trichosanthis 100-150 weight portion
2, pharmaceutical composition as claimed in claim 1 is characterized in that this pharmaceutical composition made by following crude drug:
Semen Vaccariae 133 weight portion Medulla Tetrapanaciss 133 weight portions
Radix Rehmanniae Preparata 167 weight portion Radix Angelicae Sinensis 67 weight portions
The Radix Paeoniae Alba 111 weight portion Rhizoma Chuanxiongs 50 weight portions
Herba Leonuri 133 weight portion Radix Trichosanthis 133 weight portions
3, preparation of drug combination method as claimed in claim 1 or 2 is characterized in that this method is:
Radix Rehmanniae Preparata, Radix Angelicae Sinensis, Rhizoma Chuanxiong is made solvent with 70-80% ethanol, carries out percolation, and percolate reclaims ethanol, concentrates standby; Medulla Tetrapanacis was soaked 1-3 hour, decocted 1-3 hour, filtered, decoct 1-3 time in filtrate adding Semen Vaccariae, the Radix Paeoniae Alba, the Herba Leonuri, each 1-2 hour, filter filtrate for later use, Radix Trichosanthis is used hot water warm macerating 1-3 hour, filter, filtrate and above-mentioned each extracting solution merge, and concentrate, standing over night is got supernatant concentration to clear paste.Add acceptable auxiliary or excipient on the preparation, make clinical acceptable forms.
4, preparation of drug combination method as claimed in claim 3 is characterized in that this method is:
Radix Rehmanniae Preparata, Radix Angelicae Sinensis, Rhizoma Chuanxiong is made solvent with 70% ethanol, carries out percolation, and percolate reclaims ethanol, concentrates standby; Medulla Tetrapanacis was soaked 2 hours, decocted 1 hour, filtered, decoct 2 times in filtrate adding Semen Vaccariae, the Radix Paeoniae Alba, the Herba Leonuri, each 1.5 hours, filter, filtrate for later use, Radix Trichosanthis is used hot water warm macerating 2 hours, filters, and filtrate and above-mentioned each extracting solution merge, concentrate, standing over night is got supernatant concentration to clear paste, makes soft extract.
5, preparation of drug combination method as claimed in claim 3 is characterized in that this method is:
Radix Rehmanniae Preparata 80% ethanol, Radix Angelicae Sinensis, Rhizoma Chuanxiong is made solvent with 70% ethanol, carries out percolation, and percolate reclaims ethanol, concentrates standby; Medulla Tetrapanacis was soaked 1 hour, decocted 2 hours, filtered, decoct 1 time in filtrate adding Semen Vaccariae, the Radix Paeoniae Alba, the Herba Leonuri, 1.5 hours, filter, filtrate for later use, Radix Trichosanthis is used hot water warm macerating 2 hours, filters, and filtrate and above-mentioned each extracting solution merge, concentrate, standing over night is got supernatant concentration to clear paste, adds dextrin and makes granule.
6, the method for quality control of pharmaceutical composition as claimed in claim 1 or 2 is characterized in that discrimination method in this method can be selected from one or more in the following discrimination method:
A; get soft extract 50ml of the present invention, add dehydrated alcohol 70ml, the limit edged stirs; restir 8-12 minute; leave standstill, and inclines and gets upper strata liquid evaporate to dryness, and residue adds saturated nacl aqueous solution 20ml to be made dissolving and is transferred in the separatory funnel; with water saturation n-butanol extraction 2-4 time; each 10-30ml, merge n-butyl alcohol liquid, with 3-5% ammonia spirit washing 1-3 time; each 10-30ml; reuse saturated nacl aqueous solution washing 2-4 time, 10-30ml gets n-butyl alcohol liquid evaporate to dryness; residue adds methanol 15ml; supersound process 10-20 minute at every turn, filtration, filtrate evaporate to dryness; residue adds methanol 1ml makes dissolving, as need testing solution; Other gets Semen Vaccariae control medicinal material 5 weight portions, adds 60-90 ℃ of petroleum ether 10-30ml, and reflux 1-1.5 hour, filter, filtering residue volatilizes, and adds ethanol 20-30ml, reflux 20-35 minute, puts cold; Filter, filtrate evaporate to dryness, residue add saturated nacl aqueous solution 20-30ml to be made dissolving and is transferred in the separatory funnel, shines medical material solution in pairs with legal system; Test according to thin layer chromatography, drawing above-mentioned two kinds of each 5ul of solution puts respectively on same silica gel weight portion lamellae, with 14-16: 38-41-: 20-24: lower floor's solution that 8-11 chloroform-ethyl acetate--methanol---water was placed 10-12 hour below 5～10 ℃ is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to speckle colour developing at 100-110 ℃; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color;
B, get soft extract 50ml of the present invention, add dehydrated alcohol 70ml limit edged and stir restir 8-12 minute, leave standstill, incline and get upper strata liquid, 25-35ml adds diethyl ether, standing over night is inclined and is got upper strata liquid, steams near and does, add dehydrated alcohol 7ml, ether 3ml supersound process 10-20 minute, gets upper strata liquid, the evaporate to dryness residue adds ethanol 1ml dissolving, as need testing solution; Other gets Radix Rehmanniae Preparata control medicinal material 5 weight portions, and section adds ethanol 18-22ml, and reflux 0.5-1 hour, put coldly, filter the filtrate evaporate to dryness, residue adds methanol 1ml makes dissolving, in contrast medical material solution; According to thin layer chromatography test, draw above-mentioned two kinds of each 5ul of solution, put respectively on same silica gel weight portion lamellae, be developing solvent with 60-90 ℃ of petroleum ether-ethanol acetate of 1-2: 1-2, launch, take out, dry; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical yellow spotting;
C, get soft extract 8g of the present invention, accurately claim surely, add water 18-22ml and fully stir and make dissolving, pass through macroporous adsorptive resins, wet method dress post, internal diameter 12-16mm, water 150-250ml eluting discards water liquid, reuse ethanol 60-80ml eluting is collected ethanol liquid, and evaporate to dryness, residue add methanol 13-16ml, supersound process 11-20 minute, filter, filtrate is transferred in the 25ml measuring bottle, add methanol to scale, shake up, get above-mentioned solution 15ml, evaporate to dryness, residue add methanol 1-2ml makes dissolving, as need testing solution; Other gets the peoniflorin reference substance, adds methanol and makes the solution that every 1ml contains 2mg, in contrast product solution; Test according to thin layer chromatography, draw above-mentioned two kinds of each 4ul of solution, put respectively on same silica gel weight portion lamellae, with 38-42: 3-6: 8-12: 0.1-0.3 chloroform-ethyl acetate-methanol-formic acid is developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear that hot blast blows to the speckle colour developing; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
D, get soft extract 50ml of the present invention, add dehydrated alcohol 70ml limit edged and stir restir 8-12 minute, leave standstill, incline and get upper strata liquid, 25-35ml adds diethyl ether, standing over night is inclined and is got upper strata liquid, steams near and does, add dehydrated alcohol 7ml, ether 3ml supersound process 8-12 minute, gets upper strata liquid, the evaporate to dryness residue adds ethanol 1ml dissolving, as need testing solution; Other gets the citrulline reference substance, adds Diluted Alcohol and makes the solution that every 1ml contains the 1m weight portion, in contrast product solution; Test according to thin layer chromatography, draw need testing solution 15 μ l, reference substance solution 1 μ l, put respectively in on-silica gel weight portion lamellae, with 6-10: 1-2: 1-2: 2-4 n-butyl alcohol-dehydrated alcohol-glacial acetic acid-water is developing solvent, launches, take out, dry, spray is with ninhydrin solution, and it is clear to be heated to speckle colour developing at 100-110 ℃; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
7, method of quality control as claimed in claim 6 is characterized in that discrimination method in this method can be selected from one or more in the following discrimination method:
A. get soft extract 50ml of the present invention, add dehydrated alcohol 70ml, the limit edged stirs, restir 10 minutes, leave standstill, incline and get upper strata liquid evaporate to dryness, residue add saturated nacl aqueous solution 20ml make the dissolving and be transferred in the separatory funnel, with water saturation n-butanol extraction 3 times, each 20ml merges n-butyl alcohol liquid, with 5% ammonia spirit washing 2 times, each 20ml, reuse saturated nacl aqueous solution washing 3 times, each 20ml gets n-butyl alcohol liquid evaporate to dryness, residue adds methanol 15ml, supersound process 15 minutes filters the filtrate evaporate to dryness, residue adds methanol 1ml makes dissolving, as need testing solution; Other gets Semen Vaccariae control medicinal material 5 weight portions, adds 60-90 ℃ of petroleum ether 20ml, and reflux 1 hour filters, and filtering residue volatilizes, and adds ethanol 25ml, and reflux 30 minutes is put cold; Filter, filtrate evaporate to dryness, residue add saturated nacl aqueous solution 20ml to be made dissolving and is transferred in the separatory funnel, shines medical material solution in pairs with legal system; Test according to thin layer chromatography, drawing above-mentioned two kinds of each 5ul of solution puts respectively on same silica gel weight portion lamellae, with 15: 40: 22: lower floor's solution that 10 chloroforms-ethyl acetate--methanol---water was placed 12 hours below 5～10 ℃ was developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to speckle colour developing at 105 ℃; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color;
B. get soft extract 50ml of the present invention, add dehydrated alcohol 70ml limit edged and stir restir 10 minutes, leave standstill, incline and get upper strata liquid, 30ml adds diethyl ether, standing over night is inclined and is got upper strata liquid, steams near and does, add dehydrated alcohol 7ml, ether 3ml, supersound process 10 minutes is got upper strata liquid, the evaporate to dryness residue adds ethanol 1ml dissolving, as need testing solution; Other gets Radix Rehmanniae Preparata control medicinal material 5 weight portions, and section adds ethanol 20ml, and reflux 0.5 hour is put coldly, filters the filtrate evaporate to dryness, and residue adds methanol 1ml makes dissolving, in contrast medical material solution; According to the thin layer chromatography test, draw above-mentioned two kinds of each 5ul of solution, put respectively on same silica gel weight portion lamellae, be developing solvent with 2: 1 60-90 ℃ petroleum ether-ethanol acetate, launch, take out, dry; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show identical yellow spotting;
C. get soft extract 8g of the present invention, accurate claim surely, add water 20ml and fully stir and make dissolving, by the D101 macroporous adsorptive resins, wet method dress post, internal diameter 15mm, water 200ml eluting discards water liquid, reuse ethanol 70ml eluting is collected ethanol liquid, and evaporate to dryness, residue add methanol 15ml, supersound process 15 minutes filters, and filtrate is transferred in the 25ml measuring bottle, add methanol to scale, shake up, get above-mentioned solution 15ml, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Other gets the peoniflorin reference substance, adds methanol and makes the solution that every 1ml contains 2mg, in contrast product solution; According to the thin layer chromatography test, draw above-mentioned two kinds of each 4ul of solution, put respectively on same silica gel weight portion lamellae, with 40: 5: 10: 0.2 chloroform-ethyl acetate-methanol-formic acid was developing solvent, launched, and took out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear that hot blast blows to the speckle colour developing; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
D. get soft extract 50ml of the present invention, add dehydrated alcohol 70ml limit edged and stir restir 10 minutes, leave standstill, incline and get upper strata liquid, 30ml adds diethyl ether, standing over night is inclined and is got upper strata liquid, steams near and does, add dehydrated alcohol 7ml, ether 3ml, supersound process 10 minutes is got upper strata liquid, the evaporate to dryness residue adds ethanol 1ml dissolving, as need testing solution; Other gets the citrulline reference substance, adds Diluted Alcohol and makes the solution that every 1ml contains the 1m weight portion, in contrast product solution; Test according to thin layer chromatography, draw need testing solution 15 μ l, reference substance solution 1 μ l, put respectively on same-silica gel weight portion lamellae, with 8: 2: 2: 3 n-butyl alcohol-dehydrated alcohol-glacial acetic acid-water was developing solvent, launched, take out, dry, spray is with ninhydrin solution, and it is clear to be heated to speckle colour developing at 105 ℃; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;
8, the method for quality control of pharmaceutical composition as claimed in claim 1 or 2 is characterized in that the content assaying method in this method is:
According to high effective liquid chromatography for measuring, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; 24-26: 70-80 methanol--water is mobile phase; The detection wavelength is 230nm; Number of theoretical plate calculates by peoniflorin should be not less than 3000; The preparation of reference substance solution, precision take by weighing peoniflorin reference substance 10mg, put in the 50ml measuring bottle, add dissolve with methanol and are diluted to scale, shake up; The accurate 5ml that draws puts and adds methanol in the 10ml measuring bottle and be diluted to scale, shakes up, that is, every 1ml contains peoniflorin 0.1mg.Soft extract 8g of the present invention is got in the preparation of need testing solution, accurate claims surely, adds water 20ml and fully stirs and make dissolving, by macroporous adsorptive resins, wet method dress post, internal diameter 12-16mm, water 150-250ml eluting discards water liquid, reuse ethanol 60-80ml eluting, collect ethanol liquid, evaporate to dryness, residue add methanol 12-16ml, supersound process 12-16 minute, filter, filtrate is transferred in the 25ml measuring bottle, add methanol to scale, shake up, promptly; Algoscopy, accurate respectively reference substance solution and each 10ul of need testing solution of drawing injects chromatograph of liquid, measures, promptly; The every 1g of soft extract of the present invention contains peoniflorin (C
23H
28O
11) must not be less than 0.25mg.
9, method of quality control as claimed in claim 8 is characterized in that the content assaying method in this method is:
According to high effective liquid chromatography for measuring, chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; 25: 75 methanol--water is mobile phase; The detection wavelength is 230nm; Number of theoretical plate calculates by peoniflorin should be not less than 3000; The preparation of reference substance solution, precision take by weighing peoniflorin reference substance 10mg, put in the 50ml measuring bottle, add dissolve with methanol and are diluted to scale, shake up; The accurate 5ml that draws puts and adds methanol in the 10ml measuring bottle and be diluted to scale, shakes up, that is, every 1ml contains peoniflorin 0.1mg.Soft extract 8g of the present invention is got in the preparation of need testing solution, accurate claims surely, adds water 20ml and fully stirs and make dissolving, by the D101 macroporous adsorptive resins, wet method dress post, internal diameter 15mm, water 200ml eluting discards water liquid, reuse ethanol 70ml eluting, collect ethanol liquid, evaporate to dryness, residue add methanol 15ml, supersound process 15 minutes filters, and filtrate is transferred in the 25ml measuring bottle, add methanol to scale, shake up, promptly; Algoscopy, accurate respectively reference substance solution and each 10ul of need testing solution of drawing injects chromatograph of liquid, measures, promptly; The every 1g of soft extract of the present invention contains peoniflorin (C
23H
28O
11) must not be less than 0.25mg.
10, pharmaceutical composition as claimed in claim 1 or 2 has application in the medicine that strengthens lactation amount or improve serum prolactin antagonist secretion level in preparation.
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| CN102048841A (en) * | 2009-11-10 | 2011-05-11 | 天津天士力制药股份有限公司 | Lactogenic traditional Chinese medicine composition and preparation method thereof |
| CN102813775A (en) * | 2012-07-28 | 2012-12-12 | 李梅 | Retinervus luffae fructus traditional Chinese medicine for promoting lactation |
| CN102813732A (en) * | 2012-07-28 | 2012-12-12 | 李梅 | Traditional Chinese medicine for promoting lactation after childbirth |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102048841A (en) * | 2009-11-10 | 2011-05-11 | 天津天士力制药股份有限公司 | Lactogenic traditional Chinese medicine composition and preparation method thereof |
| CN102048841B (en) * | 2009-11-10 | 2013-12-04 | 天士力制药集团股份有限公司 | Lactogenic traditional Chinese medicine composition and preparation method thereof |
| CN102813775A (en) * | 2012-07-28 | 2012-12-12 | 李梅 | Retinervus luffae fructus traditional Chinese medicine for promoting lactation |
| CN102813732A (en) * | 2012-07-28 | 2012-12-12 | 李梅 | Traditional Chinese medicine for promoting lactation after childbirth |
| CN102836269A (en) * | 2012-07-28 | 2012-12-26 | 李梅 | Euphorbia maculata lactation promoting Chinese medicine |
| CN102928524A (en) * | 2012-08-10 | 2013-02-13 | 漳州片仔癀药业股份有限公司 | Quality detection method of milk-increasing paste and correlated preparation thereof |
| CN103637281A (en) * | 2013-11-21 | 2014-03-19 | 威海五谷怡健食品有限公司 | Functional food for postpartum lactogenesis and lactation promotion and preparation method thereof |
| CN105055495A (en) * | 2015-08-28 | 2015-11-18 | 广州国宇医药科技有限公司 | Application of campylotropis macrocarpa in preparation of milk secretion promoting product |
| CN106177528A (en) * | 2016-06-07 | 2016-12-07 | 赵承博 | Treatment postpartum milk secretion obstacle and the Chinese medicine composition of lactogenic deficiency |
| CN111265448A (en) * | 2020-03-30 | 2020-06-12 | 江南大学 | Cowherb seed extract toning lotion and preparation method thereof |
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